Product News and Recalls

Pradaxa approval cited as result of flawed FDA process

An article in the Journal of the American Medical Association alleges that an effort by the U.S. Food and Drug Administration to speed approval of new medicines has led to drugs making it onto the market without proper safety analysis.

The article specifically mentions the blood thinner Pradaxa, the Wall Street Journal reports.

The JAMA article is by Thomas J. Moore, who has written two books on drug safety and is director of QuarterWatch, an independent drug-safety publication that evaluates side-effect data reported to the FDA; and Curt D. Furberg, an emeritus professor of medicine at Wake Forest University and a researcher on clinical studies.

Pradaxa’s selling point is that it’s in some ways easier to use than the decades-old competing anticoagulant, warfarin, the Wall Street Journal notes. But Moore and Furberg cite Pradaxa’s bleeding risk, and write that bleeding with Pradaxa patients “may be more difficult to treat than warfarin-related bleeding.”

They also write that “no antidote is available for use in bleeding emergencies” linked to Pradaxa.

According to the Wall Street Journal, FDA officials admit that the agency has placed a greater emphasis in recent years on getting drugs onto the market sooner.

But the article quotes Steven E. Nissen, chairman of cardiovascular medicine at the Cleveland Clinic, as saying that the FDA could do a better job of preventing unsafe drugs from entering the market. Nissen says the FDA should insist that companies produce more safety and effectiveness data soon after the drug is approved, and also insist on automatic withdrawal of a drug if the data don’t materialize.

Nissen is quoted as saying: “Once a drug is approved, it is often very difficult to put the genie back in the bottle.”

You should consult with a doctor if you have any ongoing symptoms or health concerns, and before making any changes in medication. You should also consult with a lawyer if you have injuries connected with Pradaxa.

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